JOHNSONS BABY CARE ESSENTIALS GIFT SET- zinc oxide kit

Johnsons Baby Care Essentials Gift Set by

Drug Labeling and Warnings

Johnsons Baby Care Essentials Gift Set by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DESITIN ® Maximum Strength Zinc Oxide Diaper Rash Paste

Drug Facts

Active ingredient

Zinc Oxide 40%

Purpose

Skin Protectant

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

When using this product

• do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• change wet and soiled diapers promptly
• cleanse the diaper area
• allow to dry
• apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

• store at 20°C to 25°C (68°F to 77°F)
• may stain clothing

Inactive ingredients

Petrolatum, Cod Liver Oil, Lanolin, Talc, Glycerin, Sorbitan Sesquioleate, Beeswax, Tocopheryl Acetate, Fragrance

Questions?

Call toll-free 800-720-3843 or 215-273-8755 (collect)

For more information on preventing and treating diaper rash, visit www.desitin.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Package

JOHNSON'S®

baby care essentials

value

pack

all products are

TSA compliant!

Includes JOHNSON'S® HEAD-TO TOE® wash and shampoo 3.4 FL OZ (100 mL) ● JOHNSON'S® baby lotion 3.4 FL OZ (100 mL)

DESITIN® Maximum Strength Zinc Oxide Diaper Rash Paste 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

JOHNSONS BABY CARE ESSENTIALS GIFT SET 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0789

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0789-9	1 in 1 PACKAGE	02/01/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	28 g
Part 2	1 BOTTLE	100 mL
Part 3	1 BOTTLE	100 mL

Part 1 of 3

DESITIN MAXIMUM STRENGTH DIAPER RASH  
zinc oxide paste

Product Information
Item Code (Source)	NDC: 69968-0061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
COD LIVER OIL (UNII: BBL281NWFG)
LANOLIN (UNII: 7EV65EAW6H)
TALC (UNII: 7SEV7J4R1U)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
YELLOW WAX (UNII: 2ZA36H0S2V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0061-1	1 in 1 CARTON
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/16/2015

Part 2 of 3

JOHNSONS HEAD TO TOE WASH 
baby shampoos [baby products] liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
INGR	PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		07/09/2018

Part 3 of 3

JOHNSONS BABY 
lotions, oils, powders, and creams [baby products] lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	P-ANISIC ACID (UNII: 4SB6Y7DMM3)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		07/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/01/2023

Labeler - Kenvue Brands LLC (118772437)